An observational study in Emphysema, COPD and Severe Emphysema, sponsored by Pulmonx Corporation. Recruiting at 17 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pulmonx Corporation · Observational
This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.
This is a multicenter, prospective, observational surveillance across 20 centers in Japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for BLVR using Zephyr Endobronchial Valve (EBV, Pulmonx Corporation) and confirmed to have little to no collateral ventilation in the target lobe.
Enrolled (consented) subjects will undergo a bronchoscopy procedure with the Chartis assessment to confirm that little to no collateral ventilation is present (CV- status) followed by EBV placement in the most diseased lobe. Subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months.
Subjects with collateral ventilation will be exited from the surveillance without treatment.
The primary endpoint is incidence rate of pneumothorax at Day 45 post-index procedure.
The effectiveness will be evaluated from Baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. A high-resolution computed tomography (HRCT) will be performed at Day 45 and Month 12 to determine Treated Lobe Volume Reduction (TLVR). Lung function will be assessed at Month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (FEV1), residual volume (RV) and 6 Minutes Walking Distance. The safety will be evaluated based on incident rate of treatment emergent adverse events through Month 12.
Subjects will be required to complete a pulmonary rehabilitation program between Day 45 and Month 3 per local/national guidelines.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 140 is close to the median of 131 across 111 observational studies indexed under Emphysema.
Browse Emphysema studies →Pulmonx Corporation is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The surveillance population will be adult patients (18 years or older) in Japan with hyperinflation of the lungs due to severe emphysema who are considered by their treating physician to be appropriate candidates for BLVR using Zephyr Valve and confirmed to have little to no collateral ventilation (CV-) in the target lobe. The surveillance will enroll all patients treated at the participating hospitals who provide written informed consent.
Inclusion Criteria:
Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:
Exclusion Criteria: None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bronchoscopic lung volume reduction with Zephyr Valves
Device: Zephyr Endobronchial Valve
Zephyr Valve provides an alternative technique to achieve bronchoscopic lung volume reduction (BLVR) using a minimally invasive approach. Zephyr Valve is a tiny unidirectional valve. During BLVR, multiple valves are placed to occlude a hyperinflated lobe of the lungs, allowing air to escape while blocking airflow into the treated lobe. This is intended to result in a reduction in lung volume and hyperinflation in the targeted area. Consequently, the remaining lobes can expand more fully, the overall lung works more efficiently, with resultant improvement in overall lung function in patients with hyperinflation associated with severe emphysema.
Incidence rate of pneumothorax at 45-days post-Zephyr Valve index procedure.
The percentage of study subjects who experience pneumothorax within 45-days post-Zephyr Valve index procedure.
Time frame: 45-days post-Zephyr Valve index procedure
Forced Expiratory Volume in 1 second (FEV1)
The volume of air in liters exhaled in the first second during forced exhalation after maximal inspiration. The MCID is a volume increase by at least 12%.
Time frame: Month 3, 6, 12
Residual Volume (RV)
The volume of air in remaining in the lungs after maximum forceful expiration. The MCID is a decrease by at least 310 mL.
Time frame: Month 3, 12
Treated lobe volume reduction (TLVR)
Treated lobe volume reduction is determined by HRCT and measured from Baseline to a given timepoint in mL and percentage of subjects achieving a ≥ 350 mL decrease
Time frame: Day 45, Month 12
Six-Minute Walk Distance (6MWD)
Measures the distance (in m) an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes. The MCID is an increase of 6MWD by at least 26 m.
Time frame: Month 3, 6, 12
Modified Medical Research Council Dyspnea (mMRC) Scale score
A self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 as follows: * 0: Dyspnea only with strenuous exercise * 1: Dyspnea when hurrying or walking up a slight hill * 2: Walks slower than people of same age because of dyspnea or has to stop for breath when walking at own pace * 3: Stops for breath after walking 100 yards (91 m) or after a few minutes * 4: Too dyspneic to leave house or breathless when dressing The MCID is a total score reduction by at least 1 point.
Time frame: Month 3, 6, 12
St. George's Respiratory Questionnaire (SGRQ) Total Score
A validated, disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Total score for 3 component domains (impact, activity, symptoms) ranges from 0 to 100. Higher score indicates worse quality of life. The MCID is a decrease by at least 4 points.
Time frame: Month 3, 6, 12
Plan to share: No — All data will be aggregated and analyzed. No IPD will be made available for sharing to other researchers.
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